AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 13, 2023
A tiny fraction of people are naturally resistant to HIV infections, and scientists want to understand why. Now an international team of researchers has discovered a new genetic variant in people of African ancestries that appears to restrict HIV replication after an infection sets in.
ProRelix Research
AUGUST 13, 2023
Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without […] The post Software as a Medical Devices (SaMD) and US FDA Guidance for their Clinical Evaluation and Clinical … appeared first on ProRelix Research.
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BioSpace
AUGUST 13, 2023
Valneva’s chikungunya vaccine candidate will have to wait three more months for a decision from the regulator, potentially giving rival Bavarian Nordic additional time to catch up.
JAMA Internal Medicine
AUGUST 13, 2023
This cohort study examines the associations between incident dementia and long-term fine particulate matter expressed as total mass and fine particulate matter from unique emission sources.
BioSpace
AUGUST 13, 2023
The legal complaint, filed with the Scripps Research Institute, alleges that Dexcel Pharma Technologies’ plan to sell a generic version of Pfizer's Vyndamax (tafamidis) infringes on three patents.
pharmaphorum
AUGUST 13, 2023
Cigna takes Virgin Pulse for its health plan members Phil.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
JAMA Internal Medicine
AUGUST 13, 2023
This cohort study assesses whether an intensive lifestyle intervention for weight loss among individuals with both type 2 diabetes and overweight or obesity was associated with changes in employment, earnings, and disability benefit receipt.
BioSpace
AUGUST 13, 2023
Insilico’s AI platform has attracted interest from a growing number of biopharma companies. Meanwhile, several other firms highlight their own AI technologies.
pharmaphorum
AUGUST 13, 2023
FDA clears J&J's 2-in-1 tablet for prostate cancer Phil.
BioSpace
AUGUST 13, 2023
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
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JAMA Internal Medicine
AUGUST 13, 2023
This Teachable Moment describes a 33-year-old woman with decreasing transaminase levels on repeated testing and ultrasonography showing fatty infiltration.
BioSpace
AUGUST 13, 2023
J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.
Drug Patent Watch
AUGUST 13, 2023
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Italy. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Italy? appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog
AUGUST 13, 2023
By Riëtte van Laack — On August 7, 2023, a little less than five months before the registration and listing of cosmetic product facilities and products becomes mandatory, FDA announced the availability of a draft guidance regarding the new facility registration and product listing requirements under the Modernization of Cosmetic Regulations Act of 2022 (MOCRA).
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